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Är biosimilarer till adalimumab lika effektiva och säkra vid behandling av reumatoid artrit som det biologiska referensläkemedlet adalimumab (Humira)?
Linnaeus University, Faculty of Health and Life Sciences, Department of Chemistry and Biomedical Sciences.
2018 (Swedish)Independent thesis Basic level (degree of Bachelor), 10 credits / 15 HE creditsStudent thesis
Abstract [sv]

Reumatoid artrit (RA) är en typ av reumatisk sjukdom där uttalad inflammation uppstår i flertalet leder tillsammans med smärta och stelhet. Inflammationen uppkommer som resultat av en autoimmun reaktion. I Sverige har ungefär 1 % av befolkningen RA och sjukdomen är 2–3 gånger vanligare hos kvinnor än hos män. Adalimumab (Humiraâ) är en TNF-hämmare som används vid behandling av RA. Humira är en humaniserad monoklonal antikropp som binder till TNF och neutraliserar de effekter som TNF utövar och reducerar på så vis symtom samt bromsar progressionen av RA. Under 2018 beräknas Humira utsättas för konkurrens av biosimilarer, vilka innehåller en version av den verksamma substansen som finns i det biologiska referensläkemedlet. För att en biosimilar ska godkännas krävs det att de bland annat har jämförbar effekt och säkerhet som referensläkemedlet. Syftet med denna litteraturstudie var att undersöka om biosimilarer till adalimumab är lika effektiva och säkra vid behandling av RA som det biologiska referensläkemedlet Humira. De fem artiklar som analyserats i denna litteraturstudie hittades via sökning i databasen PubMed med sökorden “rheumatoid arthritis”, “adalimumab” och “biosimilar”. Totalt gav detta 38 träffar varav 5 artiklar valdes ut. Enligt de resultat som sågs i denna litteraturstudie kan det konstateras att de fem biosimilarer som undersökts hade likvärdig effekt som referensläkemedlet adalimumab (Humiraâ) vid behandling av RA. Fyra av fem studier visade även att immunogenicitet mellan biosimilar och Humira var likvärdig. Liknande biverkningar förekom i båda behandlingsgrupper och behandling med en biosimilar gav inte fler eller allvarligare biverkningar än behandling med Humira. Lansering av biosimilar till adalimumab kommer troligtvis leda till lägre behandlingskostnader och därmed till att fler patienter kan få möjlighet till behandling.

Abstract [en]

Rheumatoid arthritis (RA) is a type of rheumatic disease where pronounced inflammation occurs in several joints along with pain and stiffness. The inflammation occurs as a result of an autoimmune reaction. In Sweden, approximately 1% of the population has RA and the disease is 2-3 times more common among women than men. One of the proinflammatory cytokines that plays a major role in RA is tumor necrosis factor (TNF). TNF is produced primarily by macrophages in the synovial membrane and has been shown to regulate release of other cytokines like IL-1 and IL-6. TNF also contributes to the release of metalloproteases from fibroblasts, reduced synthesis of proteoglycan from chondrocytes and to monocytes differentiate into osteoclasts. In this way, TNF contributes to joint destruction. Adalimumab (Humiraâ) is a TNF-inhibitor used in the treatment of RA. Humira is a humanized monoclonal antibody that binds to TNF and neutralizes the effects that TNF exerts and thus reduces symptoms and inhibits the progression of RA. In 2018, Humira is expected to be exposed to biosimilars competition. Biosimilars contains a version of the active substance in the biological reference drug and in order for a biosimilar to be approved it is necessary that they have comparable effect and safety as the reference drug. The purpose of this literature study was to investigate whether biosimilars to adalimumab are as effective and safe in the treatment of RA as the biological reference drug Humira. The five articles analyzed in this literature study were found through a search in the PubMed database with the words "rheumatoid arthritis", "adalimumab" and "biosimilar". In total, this resulted in 38 hits, of which 5 were selected. According to the results seen in this literature study, it can be noted that the five biosimilars investigated had similar effect as the reference drug adalimumab (Humira) in the treatment of RA. Four out of five studies also showed that the immunogenicity between the biosimilar and Humira was similar. Similar side effects occurred in both treatment groups and treatment with a biosimilar did not give more or more serious side effects than treatment with Humira. The launch of biosimilar adalimumab is likely to result in lower treatment costs and cost savings, as a result of the price competition that may occur between biosimilar adalimumab and the reference drug Humira. How much the cost will fall is hard to predict, but if there is a 58% reduction previously seen with other launched biosimilars, it can result in a cost saving of SEK 635 million. However, the amount of price reduction remains to be seen.

Place, publisher, year, edition, pages
2018. , p. 44
Keywords [sv]
Reumatoid artrit, adalimumab, biosimilar
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:lnu:diva-74984OAI: oai:DiVA.org:lnu-74984DiVA, id: diva2:1213180
Subject / course
Pharmacy
Educational program
Bachelor of Science Programme in Pharmacy, 180 credits
Supervisors
Examiners
Available from: 2018-06-05 Created: 2018-06-04 Last updated: 2018-06-05Bibliographically approved

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